Relative Bioavailability Study to Assess Two Solid Formulations Compared to an Oral Solution of AZD3293 in Healthy Male and Non-Fertile Female Subjects - BA
Study identifier:D5010C00005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1, Open-label, Randomized, Single-dose, 3-period Cross-over, Relative Bioavailability Study to Assess Two Solid Formulations Compared to an Oral Solution of AZD3293 in Healthy Male and Non-Fertile Female Subjects
Medical condition
Healthy Volunteers, Pharmacologic action
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD3293 oral solution, AZD3293 tablet formulation A, AZD3293 tablet formulation B
Sex
All
Actual Enrollment
1
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Feb 2014
Primary Completion Date: 01 Mar 2014
Study Completion Date: 01 Mar 2014
Study design
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Apr 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD3293 oral solution single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) | Drug: AZD3293 oral solution Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and solution as a single dose on Day 1, Day 8 or Day 15. Other Name: Beta secretase inhibitor |
| Experimental: AZD3293 tablet formulation A single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) | Drug: AZD3293 tablet formulation A Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8, or Day 15. Other Name: beta secretase inhibitor |
| Experimental: AZD3293 tablet formulation B single doses in random order in 3 study periods for each subject (Day 1 or Day 8 or Day 15) | Drug: AZD3293 tablet formulation B Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8 or Day 15. Other Name: Beta secretase inhibitor |
